Cleared Traditional

K862311 - SCREW DRIVER/BONE SCREW WRENCH/TAP & GU...

K862311 is an FDA 510(k) clearance for SCREW DRIVER/BONE SCREW WRENCH/TAP & GU..., manufactured by Warsaw Orthopedic, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K862311 · Warsaw Orthopedic, Inc. · Orthopedic device
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Jul 1986
Decision
38d
Days
Class 2
Risk

K862311 is an FDA 510(k) clearance for the SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 25, 1986 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Warsaw Orthopedic, Inc. devices

FDA 510(k) Submission Details - K862311

510(k) Number K862311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1986
Decision Date July 25, 1986
Days to Decision 38 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 122d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 298
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K862311.
MODIFIED TROCHANTER CABLE GRIP SYSTEM
K872224 · Howmedica Corp. · Aug 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
K872223 · Howmedica Corp. · Jun 1987
RICHARDS EXTERNAL FIXATION SYSTEM
K870961 · Richards Medical Co., Inc. · Mar 1987
DEPUY COMPRESSION HIP SCREW SYSTEM
K861178 · Depuy, Inc. · Apr 1986
KIRSCHNER COMPRESSION HIP SCREW SYSTEM
K854205 · Kirschner Medical Corp. · Nov 1985
MEC DISTAL FEMORAL BOLT
K850403 · Pfizer, Inc. · Jul 1985